Preliminary Results 2000
Oxford Biomedica PLC
26 January 2001
For further information, please contact:
Oxford BioMedica plc
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
City/Financial Enquiries:
David Simonson/Melanie Toyne Sewell
Merlin Financial Communications Tel: +44 (0)20 7606 1244
Scientific/Trade Press Enquiries:
Chris Gardner, HCC.De Facto Group Tel: +44 (0)20 7496 3300
OXFORD BIOMEDICA PRELIMINARY RESULTS FOR
THE YEAR ENDED 31 DECEMBER 2000
. Financial performance: turnover for the year ended 31 December 2000 was £0.7
million (1999: £0.4 million), with revenue from 3 new commercial alliances.
Loss after tax was £5.0 million (1999: £4.2 million).
. Research & development: R&D expenditure was £5.0 million (1999: £3.8
million), which included the establishment of the Gene Discovery Division.
. Cash position: the bank balance at 31 December 2000 was £11.6 million (1999:
£3.0 million). £14.2 million was raised, net of costs, by issues of shares,
including the placing of 13.7 million shares in January 2000 and 14.6
million shares in August 2000.
. Clinical progress: positive Phase I results from MetXia(R) with good safety
and gene transfer data in BC1 (breast cancer) trial. MetXia(R) is also in a
Phase I/II ovarian cancer trial. In January 2001 the cancer vaccine,
TroVax(TM)entered Phase I/II clinical trials in colorectal cancer.
. Commercial activity: there are now 10 commercial alliances with
pharmaceutical and biotech companies including AstraZeneca, Aventis, Nycomed
Amersham and, signed in January 2001, a collaboration with Wyeth-Ayerst
potentially worth $24 million.
. Gene discovery: This new division was established in August 2000 and has
already identified new genes believed to be mechanistically linked with
diseases such as cancer, cardiovascular disease and inflammation.
Significant progress is expected from this division in the next financial
year.
. New appointments: Dr Paul Durrands joined the Board as Commercial Director.
Dr Peter Johnson replaced Alan Goodman as non-executive Chairman.
Commenting on the Preliminary Results, Dr Peter Johnson, Chairman of Oxford
BioMedica said:
'This has been another year of substantial achievements for the Company, with
the reporting of the first clinical results for MetXia(R), approval of the
clinical trials of our second product, TroVax(TM), and the expansion of our
work in the genomics field through the Gene Discovery Division.
'We continue to focus on building shareholder value by creating as many routes
as possible for our unique technology to enter substantial pharmaceutical
markets. We are pleased with the position we have reached so far, with ten
commercial collaborations, three clinical trials in progress and a pipeline of
new opportunities, coupled with a stronger balance sheet as a result of the
successful fund-raisings in 2000. We look forward to further growth in 2001.'
Notes to Editors
1. Oxford BioMedica
Established in 1995, the Company specialises in the development and
application of gene-based therapeutics and immunotherapeutics for the
treatment of disease in the areas of Oncology, Neurobiology and Viral
Infection. During 2000 Oxford BioMedica expanded its activities by the
establishment of a Gene Discovery Division which applies the Company's
gene-based technologies in the field of genomics with the intention of
identifying genes that may be linked to disease. Oxford BioMedica plc was
floated on the Alternative Investment Market of the London Stock Exchange
in December 1996.
Currently Oxford BioMedica has corporate collaborations with Aventis,
AstraZeneca, IDM, Modex Therapeutics, Nycomed Amersham, Valentis, Virbac
and Wyeth-Ayerst. BioMedica has two products in Phase I/II clinical trials.
MetXia(R) is in clinical trials for late-stage breast cancer (BC1) and
ovarian cancer (OC1), and TroVax(TM) is in clinical trials for late-stage
colorectal cancer.
2. World Wide Web
This release is also available on the World Wide Web at:
http://www.oxfordbiomedica.co.uk
CHAIRMAN'S STATEMENT
Oxford BioMedica has made substantial progress in 2000. In November the
Company reported the successful completion of the first stage of the Phase
I/II clinical trial of MetXia(R) in cancer patients with surface skin nodule
tumours. In December BioMedica's second product, TroVax(TM), received approval
for a Phase I/II trial in colorectal cancer patients. This clinical trial
commenced in January 2001. In addition, the Company's preclinical programmes
have moved ahead well, particularly in the neurobiology field.
The formation of the Gene Discovery Division further broadened the Company's
commercial base adding another route to value as the pharmaceutical and
biotechnology industries enter the post-genome era. BioMedica now has ten
corporate alliances in place including deals with Aventis, Nycomed Amersham
and AstraZeneca and, signed in January 2001, a collaboration with Wyeth-Ayerst
to develop antibody-based products with a potential value from access, option
and milestone payments of $24 million.
FINANCIAL REVIEW
In 2000 Oxford BioMedica continued to manage its finances prudently, and was
able to take advantage of two opportunities to raise new funds in
institutional share placings.
Income was £732,000 in 2000 (1999: £436,000). The increased revenue arose from
expansion of existing collaborations with Aventis and Modex, and new
collaborations with AstraZeneca, Nycomed Amersham and Virbac. The loss for the
year after tax was £5.0 million (1999: £4.2 million).
Operating expenses were £6.8 million (1999: £5.1 million). Of this, research
and development costs were £5.0 million (1999: £3.8 million). The increased
research and development costs reflect the continuing expansion of research,
preclinical and clinical programmes, and the establishment in August 2000 of
the Gene Discovery Division. In addition it includes a substantial and growing
investment in creating and maintaining the Company's intellectual property
portfolio. Administrative expenses were £1.7 million (1999: £1.3 million).
Grant income was £0.1 million (1999: £0.3 million) as the Company completed
its three current grant programmes.
Capital expenditure in 2000 was £0.9 million (1999: £0.1 million); £0.6
million of this was used for advanced computer hardware and software to
support the implementation of bioinformatics by the Gene Discovery Division.
From April 2000 the Company is entitled to claim tax credits for certain
research and development expenditure, and consequently the 2000 accounts
include a tax credit of £0.4 million (1999: nil). Tax losses on other
expenditure will be available for offset against future taxable profits.
Financing
A total of £14.2 million was raised by the issue of shares in 2000, detailed
in the table below. With the authority given to the Directors by the Company's
shareholders, the Company was able to complete two institutional cash
placings, free of statutory pre-emption rights, to raise new funds quickly and
cost-effectively.
Price
Date Reason for issue Shares per Net
issued share Proceeds
January 2000 Institutional placing 13.7 million 38p £5.0 million
May 2000 Subscription by 3 US institutions 0.5 million 55p £0.3 million
August 2000 Institutional placing 14.6 million 60p £8.5 million
August 2000 Employee options 1.1 million 33p £0.4 million
Total amount raised £14.2 million
As a result of increased operating expenses and higher capital expenditure,
the net outflow of funds before new share issues was £5.6 million in 2000
(1999: £3.7 million). The bank balance at 31 December 2000 was £11.6 million.
The funds raised in 2000 have allowed BioMedica to increase its investment in
research and development, and in particular to establish the Gene Discovery
Division. As a result the Directors believe that the potential for future
returns from the Company's technology has been enhanced. Since it is the
Company's commercial strategy to proceed with the clinical development of
candidate products up to and including Phase I/II clinical trials, the Company
will require further funds in due course.
OPERATIONAL REVIEW
During the year the Company made good progress in its three main activities:
Gene Therapy, Gene-based Immunotherapy and Gene Discovery, and has progressed
well with its external collaborations.
Clinical Development of BioMedica's Products
Oxford BioMedica made significant advances in its clinical programmes in 2000.
In November, the Company reported that MetXia(R) had met all of the goals in
the first part of the Phase I/II BC1 trial in cancer patients with surface
skin nodule tumours, mainly arising from breast cancer. In addition the
Company was granted approval to use MetXia(R) in a Phase I/II trial (OC1) in
ovarian cancer patients, and that trial has started.
The successful completion of the first part of the BC1 trial has prompted the
Company to build a product family around MetXia(R) thereby broadening its
commercial potential. In December 2000, BioMedica established a collaboration
with the major US gene therapy company Valentis to develop a version of
MetXia(R) for systemic administration using Valentis' PEGylation technology.
In December 2000 the Company's second lead candidate product, TroVax(TM),
received approval from the Medicines Control Agency for a Phase I/II trial
(TV1) in colorectal cancer patients. The TV1 trial is being conducted at the
Christie Hospital, Manchester. Not only is this an important step in terms of
the development of TroVax(TM) as a product, but it is also a major component
of the Company's qualification for admission to the United Kingdom Listing
Authority's Official List.
Preclinical Research and Development
During the year there were a number of major technical developments and the
Company made significant progress in taking its products towards the clinic.
Two areas are worthy of special note: neurobiology and immunotherapy.
The neurobiology programme gained pace with substantial achievements from both
the LentiVector(R) team, in terms of efficiency of gene transfer to neurones,
and the neurobiology team, in terms of the development of BioMedica's
Parkinson's disease product, ProSavin(R). The Directors believe that BioMedica
has world leading technology for delivering genes to the cells of the central
nervous system, and that this will create a range of commercial opportunities
in the future.
In addition, the demonstration by the Company's immunotherapy group that an
antibody against the proprietary tumour antigen OBA-1 has direct anti-tumour
effects in model systems has opened the way for BioMedica to enter the
antibody therapy field. The signing of a collaborative agreement with a
potential value from access, option and milestone payments of US$ 24 million
in January 2001 with Wyeth-Ayerst Laboratories (a division of American Home
Products Corporation) is one example of the validation of BioMedica's antibody
technology, and further developments are expected in this area during the
coming year.
Gene Discovery Division
2000 was an historic year for biomedical science with the completion of the
sequencing of the human genome. Oxford BioMedica, as a leader in gene-based
technology, is ideally placed to realise the potential of the post-genome era,
particularly through the activities of the Gene Discovery Division.
The establishment of the Gene Discovery Division in the second half of the
year addresses the problem of identifying those genes, amongst the 100,000
genes in the genome, that are mechanistically involved in disease processes
and are therefore prime candidates as targets for product development. The
Company raised £8.5 million by a share placing in August 2000 to accelerate
the development of business opportunities in this field.
The Gene Discovery Division has already achieved commercial success through
target validation deals with AstraZeneca and Aventis, and further deals are in
discussion with both pharmaceutical companies and genomics companies. In
addition, patents have been filed covering the first genes identified using
BioMedica's proprietary Smartomics(TM) technology. These genes may have
applications in cancer, cardiovascular disease and inflammation. In the coming
year, the Company expects to make significant further progress with the Gene
Discovery Division as new collaborations are agreed and as more genes are
identified, particularly in the field of neurological disorders.
External Collaborations
The Company's collaborative alliances are progressing well. In June 2000
BioMedica announced the expansion of the collaboration with Aventis in
cardiovascular disease. In addition six new collaborations have been signed:
. January 2000 IDM S.A. in the field of cell-based therapies;
. February 2000 AstraZeneca in the field of genomics;
. February 2000 Virbac S.A. for the development of a veterinary version
of TroVax(TM);
. March 2000 Nycomed Amersham for tumour imaging;
. December 2000 Valentis Inc. for the development of MetXia(R); and
. January 2001 AHP/Wyeth in the field of anti-cancer antibody therapy.
Intellectual Property
BioMedica's intellectual property portfolio represents the foundations of the
Company's value. New patents were filed in 2000, seven patents were granted
and notices of allowance were received for a further five patents. Of
particular importance has been the Company's increasing portfolio of
successful patent applications in the field of LentiVector(R) technology.
Commercial Strategy
The BioMedica management team recognises that the commercial development of
novel therapeutics is a process that offers substantial reward, but that has a
number of associated risks. These risks are a function of the gap in knowledge
that exists between the data generated in preclinical studies and the ability
to predict efficacy of a product in human clinical trials. It is the
responsibility of any biotech management to manage that risk effectively and
BioMedica faces this challenge head-on through its technical and commercial
strategies.
The overriding principle followed by the Company is to develop as many
credible routes to major pharmaceutical markets as possible while containing
costs within strict budget constraints. BioMedica is developing in-house
technologies and a range of candidate products, designed to address unmet
medical needs where there is substantial market potential, in the areas of
cancer, neurodegenerative disease and AIDS.
Also, the Company creates market opportunities by joining with others and
applying its technology and product components to collaborative product
development projects, often outside the fields of the internal programmes. As
part of these alliances, the partner often pays for all or a significant part
of the research and development programme, and therefore the early risk to
BioMedica is reduced.
In addition the Company further leverages its proprietary technology by
supplying, through the Gene Discovery Division, leading edge capabilities to
the pharmaceutical industry for developing new products that arise out of
genomics and proteomics.
The continued pursuit of this strategy means that BioMedica's value does not
reside in any single product, product component or technology. Instead, the
Company's value is distributed across several short-term and long-term revenue
opportunities any one of which has the potential to yield substantial returns.
The directors believe, therefore, that the overall prospects for BioMedica are
good.
Appointments
In June 2000 Dr Paul Durrands joined the Board as commercial director. He has
specific responsibility for the commercial development of the Gene Discovery
Division. On 1 January 2001 Alan Goodman retired from the board of BioMedica.
Mr Goodman had served as a non-executive director for over four years and had
been chairman since June 1998. I am pleased to be extending my role as a
non-executive director and taking over the role of Chairman. I am looking
forward to being involved as Oxford BioMedica enters a year of exciting
opportunities.
IN SUMMARY
This has been an excellent year for BioMedica. A great deal has been achieved,
and there is still more to come. However, none of this would have been
possible without the dedication and extraordinary skills of our research and
development staff or the support of our shareholders, new and old. The
Directors were particularly pleased to welcome new institutional shareholders
who took part in the two share placings during 2000. The Board also extends
its thanks to Alan Goodman for his many contributions to the development of
BioMedica over its first four years.
Dr Peter Johnson
Chairman
Consolidated profit and loss account
for the year ended 31 December 2000
2000 1999
(unaudited) (audited)
£'000 £'000
Turnover 732 436
Research and development (5,033) (3,764)
Administrative expenses (1,731) (1,346)
Operating expenses (6,764) (5,110)
Other operating income: government grants receivable 96 267
Net operating expenses (6,668) (4,843)
Operating loss (5,936) (4,407)
Interest receivable 541 218
Loss on ordinary activities before taxation (5,395) (4,189)
Tax credit on loss on ordinary activities 393 -
Loss for the year (5,002) (4,189)
Basic loss and diluted loss per ordinary share (3.1p) (3.0p)
Consolidated balance sheet
at 31 December 2000
2000 1999
(unaudited) (audited)
£'000 £'000
Fixed assets
Intangible assets 283 332
Tangible assets 1,304 773
Investments 26 26
1,613 1,131
Current assets
Debtors 1,069 432
Cash at bank and in hand 11,635 3,039
12,704 3,471
Creditors: amounts falling due within one year (1,340) (801)
Net current assets 11,364 2,670
Net assets 12,977 3,801
Capital and reserves
Called-up share capital 1,721 1,422
Share premium account 26,428 12,549
Other reserve 711 711
Profit and loss account (deficit) (15,883) (10,881)
Equity shareholders' funds 12,977 3,801
Consolidated cash flow statement
for the year ended 31 December 2000
2000 1999
(unaudited) (audited)
£'000 £'000
Operating activities
Net cash outflow from continuing operating activities
(reconciliation to operating loss on page 11) (5,306) (3,800)
Returns on investments and servicing of finance
Interest received 407 218
Capital expenditure
Purchase of tangible fixed assets (683) (136)
Acquisitions and disposals
Investment in joint venture - (26)
Net cash outflow before management of liquid
resources and financing (5,582) (3,744)
Management of liquid resources
Net transfer to deposit accounts (11,092) -
Financing
Issue of ordinary shares 14,603 3,556
Expenses of share issue (425) (339)
14,178 3,217
Decrease in cash in the year (2,496) (527)
Reconciliation of operating loss to net cash outflow from operating
activities
2000 1999
(unaudited) (audited)
£'000 £'000
Continuing activities
Operating loss (5,936) (4,407)
Amortisation on intangible fixed assets 49 49
Depreciation on tangible fixed assets 321 296
Loss on disposal of fixed assets 5 1
Decrease/(increase) in trade debtors 24 (24)
(Increase)/decrease in other debtors and other tax
receivable (52) 27
Increase in prepayments and accrued income (82) (77)
Increase in trade creditors 99 162
Increase in other taxation and social security 57 29
Increase in accruals and deferred income 209 144
Net cash outflow from continuing operating activities (5,306) (3,800)
Notes to accounts
1. The preliminary results for the year ended 31 December 2000 are unaudited
and do not constitute the Company's statutory financial statements within
the meaning of s227 of the Companies Act 1985. The financial information
for the year ended 31 December 1999 is derived from the statutory accounts
for that year which have been delivered to the Registrar of Companies. The
auditor's report on those accounts was unqualified. The statutory accounts
for the year ended 31 December 2000 will be finalised on the basis of the
financial information presented by the directors in this preliminary
announcement and will be delivered to the Registrar of Companies following
the Company's Annual General Meeting.
2. The basic loss per share has been calculated on a weighted average number
of shares of 161,851,789 in issue during the year (1999: 137,599,908). The
Company had no dilutive potential shares in either period which would serve
to increase the loss per ordinary share. There is therefore no difference
between the loss per ordinary share and the diluted loss per ordinary
share.
3. Copies of this announcement are available from the Company Secretary. The
audited statutory financial statements for the year ended 31 December 2000
are expected to be distributed to shareholders by 28 February 2001 and will
be available at the registered office of the Company, Medawar Centre,
Oxford Science Park, Oxford, OX4 4GA.
4. This announcement was approved by the Board of Oxford BioMedica plc on 25
January 2001.